Strengthening Adalvo's oncology portfolio with a targeted therapy for BRAF-mutated cancers.
Zug, Switzerland, September 2026: Adalvo announced the submission of the Decentralised Procedure (DCP) for its generic Binimetinib 15 mg and 45 mg film-coated tablets in Europe. The filing was strategically submitted upon data exclusivity expiry, representing an important regulatory milestone and supporting future market access opportunities across European markets.
Binimetinib is a selective MEK1/2 inhibitor indicated, in combination with encorafenib, for the treatment of adults with unresectable or metastatic melanoma with a BRAF V600 mutation, as well as adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. As the incidence of melanoma and lung cancer continues to rise globally, access to affordable targeted therapies remains an important healthcare priority.
Global sales of Binimetinib exceeded $559 million in 2025 (IQVIA), with European sales approaching $300 million and continuing to demonstrate strong growth, reflecting sustained demand for targeted oncology therapies and the need for broader patient access across the region.
"The DCP submission of Binimetinib marks another important milestone in strengthening our oncology portfolio. As demand for targeted cancer therapies continues to grow, we remain focused on developing high-quality, accessible treatment options that create value for both patients and partners worldwide."
The submission follows the successful completion of pivotal bioequivalence studies and is supported by a clearly defined regulatory and intellectual property strategy. The programme covers both the 15 mg and 45 mg strengths and leverages Adalvo's proprietary formulation expertise to support future registrations and commercialisation opportunities across global markets.
Binimetinib further reinforces Adalvo's strategy of expanding its portfolio of complex oncology products and providing high-value opportunities for partners worldwide. The programme demonstrates Adalvo's commitment to bringing differentiated specialty generics to global markets through robust development, regulatory excellence, and commercial expertise.
Disclaimer: Products which are subject to patent protection are currently not offered or made available in countries where patents are in force.